JP5430065B2 - Guide wire - Google Patents

Description

  The present invention relates to a guide wire.

  When a catheter is inserted into a biological lumen such as a digestive tract or a blood vessel, a guide wire is used to guide the catheter to a target site in the biological lumen. This guide wire is used by being inserted into a catheter.

  In addition, observation and treatment of a living body lumen using an endoscope is also performed, and a guide is also provided for guiding a catheter inserted into the endoscope or the lumen of the endoscope to a target site such as a living body lumen. A wire is used (for example, refer patent document 1).

  This guide wire has a long wire body and a coil that covers the tip of the wire body. The coil can be composed of a radiopaque material such as a noble metal. In this case, X-ray contrast is obtained at the distal end portion of the guide wire, and the guide wire is inserted into the living body while confirming the position of the distal end portion of the guide wire under fluoroscopy.

  However, it is difficult to obtain sufficient contrast with only the coil, that is, since the contrast is low, it is difficult to grasp the position of the distal end portion of the guide wire. Therefore, it has been difficult to smoothly insert the guide wire into the living body. Further, since the guide wire is monochromatic, even if the guide wire is moved in the axial direction during the insertion operation, coupled with the low contrast described above, the amount of movement, that is, the insertion depth with respect to the target portion of the biological lumen. It was difficult to understand how much the length was.

JP 2007-135645 A

  An object of the present invention is to provide a guide wire that can reliably ensure contrast by X-rays and can reliably grasp the degree of insertion depth when the guide wire is inserted into a target portion of a living body lumen. It is in.

Such an object is achieved by the present inventions (1) to ( 8 ) below.
(1) A guide wire having a long wire main body and having a contrast portion having X-ray contrast properties formed at the tip,
The contrast portion is provided on the outer peripheral side of the wire body along the longitudinal direction thereof, and is formed of a metal member having an X-ray contrast property, covers the contrast member, and has an X-ray contrast property. And a resin coating layer to which at least a part of the contrast agent is added, and in the first contrast region, the second contrast region, and the third contrast region in order from the distal end side along the longitudinal direction of the wire body. Divided,
The second contrast region has a lower contrast than any of the first contrast region and the third contrast region,
The difference in contrast between the first contrast area and the second contrast area is that the density of the contrast member in the second contrast area is the density of the contrast member in the first contrast area. And the content of the contrast agent in the resin coating layer in the second contrast region is lower than the content of the contrast agent in the resin coating layer in the first contrast region. Has been made,
The difference in contrast between the second contrast area and the third contrast area is that the density of the contrast member in the second contrast area is the density of the contrast member in the third contrast area. And the content of the contrast agent in the resin coating layer in the second contrast region is lower than the content of the contrast agent in the resin coating layer in the third contrast region. Has been made ,
Each resin coating layer is configured at the boundary between the resin coating layer in the first contrast region, the resin coating layer in the second contrast region, and the resin coating layer in the third contrast region. The guide wire is characterized in that the fixing force of the entire resin coating layer in the contrast portion with respect to the contrast member and the wire body is increased in combination with a fixing effect due to the compatibility of the resin materials to be performed.

(2) The resin coating layer in the second contrast region is excellent in adhesiveness to the wire body and the contrast member because the contrast agent content is small, and the entire resin coating layer in the contrast portion The guide wire according to (1), which is mainly fixed to the wire body and the contrast member.

( 3 ) The guide according to (1) or (2) , wherein the constituent material of the contrast member and the contrast agent in the resin coating layer in the first contrast region are made of the same material. Wire.

( 4 ) The contrast agent in the resin coating layer in the first contrast region and the contrast agent in the resin coating layer in the second contrast region are made of different materials from each other ( The guide wire according to any one of 1) to (3) .

( 5 ) The guide wire according to any one of (1) to (4) , wherein the contrast agent is a particle made of a metal material or a metal oxide.

( 6 ) The contrast member is a coil wound in a spiral shape, and the spiral pitch in the second contrast region is the spiral pitch in the first contrast region and the third contrast region. The guide wire according to any one of (1) to (5) , which is larger than the guide wire.
( 7 ) The guide wire according to (6) , wherein the coil is configured by one linear body continuous from the first contrast region to the third contrast region.

( 8 ) The contrast member has a ring shape, and a plurality of the contrast members are arranged along the longitudinal direction of the wire body. The pitch of the adjacent contrast members in the second contrast region is The guide wire according to any one of the above (1) to (5) , which is larger than a pitch in the first contrast region and the third contrast region.

  According to the present invention, the X-ray contrast property of the contrast unit is ensured as a whole, but the X-ray contrast property is strong and weak among them, and the first contrast region, the second contrast region, and the third contrast region. There is a difference in brightness between the contrast region, that is, the contrast becomes clear. As a result, the position of the distal end portion of the guide wire can be grasped separately from other positions, and the distal end portion of the guide wire can be grasped by distinguishing it into at least three regions. Accordingly, when the guide wire is inserted into the target site of the living body lumen under X-ray fluoroscopy, where the distal end portion of the guide wire and further the three regions are located in the living body lumen, that is, the guide The degree of insertion depth of the wire with respect to the target portion can be reliably grasped. Therefore, the insertion depth can be ensured without excess or deficiency, and for example, unintentional disconnection (detachment) of the guide wire from the target site can be reliably prevented.

  When the length of the first contrast region is longer than the length of the second contrast region and the length of the second contrast region is equal to or longer than the length of the third contrast region, the guide The degree of insertion depth of the wire with respect to the target site can be grasped more reliably, and therefore a sufficient insertion depth according to the case can be ensured.

  Hereinafter, the guide wire of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a longitudinal sectional view showing a first embodiment of the guide wire of the present invention. In the following, for convenience of explanation, the right side in FIG. 1 (the same applies to FIGS. 2 to 4) is referred to as “base end”, and the left side is referred to as “tip”. In addition, in FIG. 1 (the same applies to FIGS. 2 to 4), in order to facilitate understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated and schematically illustrated. The ratio between the length direction and the thickness direction is different from the actual one.

  A guide wire 1 shown in FIG. 1 is a guide wire for a catheter (a guide wire for a transendoscope) that is used by being inserted into a lumen of a catheter (including an endoscope), and has flexibility or flexibility. It has the wire main body 2 comprised with the core wire (Linear (long shape) core material: Core) which has. The cross-sectional shape of the wire body 2 is circular.

  In the present embodiment, the wire body 2 is composed of a single continuous core wire (wire). However, the present invention is not limited to this, and the wire main body 2 may be formed by joining and connecting a plurality of core wires (wires) made of the same or different materials, for example, by welding.

  The total length of the guide wire 1 is not particularly limited, but is preferably about 200 to 5000 mm.

  In the present embodiment, the wire body 2 has a portion having a constant outer diameter and a tapered portion (outer diameter gradually decreasing portion) in which the outer diameter gradually decreases in the distal direction. The latter may be one place or two places or more. In the configuration shown in FIG. 1, the wire body 2 has one outer diameter gradually decreasing portion (taper portion) 15 at the tip portion.

By having such an outer diameter gradually decreasing portion 15, the rigidity (bending rigidity, torsional rigidity) of the wire body (core wire) 2 can be gradually decreased toward the distal end direction. Good flexibility can be obtained at the distal end portion, the followability to blood vessels and safety can be improved, and bending and the like can also be prevented.
Further, the outer diameter gradually decreasing portion 15 is a portion where a contrast portion 7 described later is disposed.

  In the configuration shown in the figure, the outer diameter gradually decreasing portion 15 is formed at the distal end portion of the wire body 2 (part of the longitudinal direction), but the entire wire body 2 constitutes the outer diameter gradually decreasing portion. Also good. In addition, the taper angle (outer diameter reduction rate) of the outer diameter gradually decreasing portion 15 may be constant along the longitudinal direction of the wire body 2, or there may be a portion that varies along the longitudinal direction. For example, a portion in which a taper angle (an outer diameter reduction rate) and a relatively small portion are alternately formed a plurality of times may be used.

  The portion of the proximal end side of the outer diameter gradually decreasing portion 15 of the wire body 2 has a constant outer diameter up to the vicinity of the proximal end portion of the wire body 2.

  The constituent material of the core wire constituting the wire body 2 is not particularly limited. All types of SUS such as SUS302), piano wire, iron-cobalt alloy, carbon steel (including extremely low carbon steel, low carbon steel, etc.), mild steel, hard steel, nickel steel, nickel chrome steel, nickel chrome molybdenum steel, etc. And various metal materials such as a cobalt-based alloy, a titanium-based alloy, and a nickel-based alloy. Among these, stainless steel is preferable because it has higher strength and rigidity than a superelastic alloy described later, and therefore can impart excellent pushability and torque transmission to the guide wire 1.

  Moreover, an alloy (including a superelastic alloy) exhibiting pseudoelasticity can be used as a constituent material of the core wire constituting the wire body 2, and a superelastic alloy is particularly preferable as an alloy exhibiting pseudoelasticity.

  Since the superelastic alloy is rich in flexibility, has a resilience, and is difficult to bend, the guide wire 1 is formed on the distal end side by forming the wire body 2 (particularly, the distal end thereof) with the superelastic alloy. Sufficient flexibility in the part and resilience to bending can be obtained, follow-up to complicatedly curved and bent blood vessels, etc., improved operability, and wire body 2 can repeatedly bend and bend However, since the bend crease is not attached due to the resilience provided in the wire main body 2, it is possible to prevent a decrease in operability due to the bend crease attached to the wire main body 2 during use of the guide wire 1.

  Pseudoelastic alloys include any shape of stress-strain curve due to tension, including those that can measure the transformation point of As, Af, Ms, Mf, etc., and those that cannot be measured. However, everything that returns to its original shape by removing stress is included.

  The preferred composition of the superelastic alloy is Ni-Ti alloy such as Ni-Ti alloy of 49-52 atomic% Ni, Cu-Zn alloy of 38.5-41.5 wt% Zn, 1-10 wt% X Cu-Zn-X alloy (X is at least one of Be, Si, Sn, Al, and Ga), 36-38 atomic% Al-Ni-Al alloy, and the like. Of these, the Ni-Ti alloy is particularly preferable. In addition, the superelastic alloy represented by Ni-Ti type alloy is excellent also in the adhesiveness of the surface layer 4 mentioned later.

  The cobalt-based alloy has a high elastic modulus when used as a wire and has an appropriate elastic limit. For this reason, the wire comprised by the cobalt type alloy is excellent in torque transferability, and problems, such as buckling, do not arise very much. Any cobalt-based alloy may be used as long as it contains Co as a constituent element, but it contains Co as a main component (Co-based alloy: Co content in the elements constituting the alloy) Is preferable, and a Co—Ni—Cr alloy is more preferably used. By using an alloy having such a composition, the above-described effects become more remarkable. In addition, an alloy having such a composition has a high elastic modulus and can be cold-formed even as a high elastic limit, and by reducing the diameter while sufficiently preventing buckling from occurring due to the high elastic limit. And can have sufficient flexibility and rigidity to be inserted into a predetermined portion.

  As described above, the wire body 2 may be formed by connecting a plurality of core wires (wires) made of different materials. For example, the wire body 2 is bonded to the first wire (first core wire) on the distal end side and the proximal end of the first wire. It can comprise with the made 2nd wire (2nd core wire). In this case, the first wire is preferably made of the above-described superelastic alloy, particularly preferably made of a Ni—Ti alloy, and the second wire is made of the aforementioned stainless steel. It is preferable. And the boundary part (joint part) of the 1st wire and the 2nd wire is a part of the base end side from the outer diameter gradually decreasing part 15, a base end of the outer diameter gradually decreasing part 15, a part in the middle of the outer diameter gradually decreasing part 15, It may be in any location.

  Further, the tip of the wire body 2 (the tip of the first wire) may have a reshapable portion (not shown) that can be reshaped (shaped).

  In the present invention, the outer peripheral surface (surface) of the wire body 2 may be subjected to a treatment (roughening treatment, chemical treatment, heat treatment, etc.) for improving adhesion with the surface layer 4 described later.

  As shown in FIG. 1, the guide wire 1 having such a wire body 2 has a contrast portion 7 having an X-ray contrast property formed at the tip thereof. The contrast section 7 includes a coil 6 as a contrast member and a coating layer (resin coating layer) 5 that covers the coil 6 provided on the outer peripheral side of the wire body 2. The contrast unit 7 is divided into a first contrast region 71, a second contrast region 72, and a third contrast region 73 in order from the distal end side along the longitudinal direction of the wire body 2. In the contrast unit 7, adjacent contrast regions have different contrast strengths (degrees), that is, there is a difference in contrast between the adjacent contrast regions.

  Further, in order to improve the safety of the guide wire 1, the distal end of the contrast unit 4 has a rounded shape.

  The coil 6 disposed on the outer periphery of the distal end portion of the wire body 2 is a member formed by winding a wire (thin wire) in a spiral shape along the circumferential direction and the longitudinal direction of the wire body 2. The coil 6 is composed of one continuous wire (linear body) from the first contrast region 71 to the third contrast region 73. As a result, good flexibility is obtained in the contrast unit 7, and the followability to the blood vessel and the safety are improved. Moreover, the number of parts which comprise the imaging | contrast part 7 can be suppressed, Therefore The manufacturing cost at the time of manufacturing the guide wire 1 can be suppressed. In addition, by making the helical pitch of the coil 6 dense, sparse, or dense from the tip side, a sudden change in physical properties can be prevented.

  The coil 6 is made of a metal material. As a metal material which comprises the coil 6, noble metals, such as gold | metal | money, platinum, tungsten, or an alloy containing these (for example, platinum-iridium alloy) etc. are mentioned, for example. Thereby, the X-ray contrast property is obtained in the guide wire 1.

  Further, the inner surface (inner surface) of the coil 6 is in close contact with the outer peripheral surface of the outer diameter gradually decreasing portion 15 of the wire body 2.

  In the case of the present embodiment, the coil 6 has a circular cross section of the wire. However, the present invention is not limited to this, and the cross section of the wire is, for example, an ellipse or a quadrangle (particularly a rectangle). Also good.

  A coating layer 5 that covers the coil 6 is formed in the contrast unit 7. The resin constituting the coating layer 5 is not particularly limited, and examples thereof include polyurethane, polyethylene, polypropylene, polyolefins such as ethylene-propylene copolymer, fluorine resins such as polytetrafluoroethylene, polyesters such as polyethylene terephthalate, poly Examples include vinyl chloride, polyamide, polyimide, ethylene-vinyl acetate copolymer, ethylene-ethylene acrylate copolymer, ABS resin, AS resin, butadiene-styrene copolymer, polyisoprene, and polybutadiene. Although it can be used in combination of two or more species, a material having a relatively high flexibility such as polyurethane is preferable because it is excellent in flexibility and adhesion to the wire body 2.

  A contrast agent made of a metal powder (metal particles) having X-ray contrast properties is added to a part of the constituent material of the coating layer 5. The metal material is not particularly limited, and examples thereof include noble metals such as tungsten, gold, and platinum, and tungsten is particularly preferable. The contrast function (contrast property) of the contrast unit 7 (the first contrast region 71, the second contrast region 72, and the third contrast region 73) can be adjusted by the type and content of the metal powder. .

The average particle diameter (average diameter) of the contrast agent in the coating layer 5 is not particularly limited, but is preferably 0.5 to 4.0 μm, for example, 1.0 to 1.5 μm. More preferred.
Moreover, the coating layer 5 may be a single layer or a laminate.

  A surface layer 4 is formed on the outer peripheral surface of the wire body 2 so as to cover all or a part thereof. In the configuration shown in FIG. 1, the surface layer 4 covers from the middle of the wire body 2 (the base end portion of the outer diameter gradually decreasing portion 15) to the base end. Although the surface layer 4 can be formed for various purposes, it is particularly preferable to form the surface layer 4 for the purpose of reducing the friction (sliding resistance) of the guide wire 1 and improving the slidability. Thereby, the operativity of the guide wire 1 improves.

  The surface layer 4 is preferably composed mainly of, for example, a fluorine resin. By using such a material, the frictional resistance (sliding resistance) between the guide wire 1 and the inner wall of the catheter or the like can be reduced more effectively, and the slidability can be improved. The operability of the guide wire 1 becomes better. In addition, this makes it possible to more reliably prevent kinking (bending) and twisting of the guide wire 1, particularly kinking and twisting in the vicinity of the welded portion, when the guide wire 1 is moved and / or rotated in the catheter.

  Examples of the fluorine-based resin include polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), and polyfluoride. Vinyl fluoride (PVF), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (PETFE), or a composite material in which two or more thereof are combined.

  Further, it is preferable that a hydrophilic material is coated on at least the outer surface of the guide wire 1. As a result, the hydrophilic material is wetted to produce lubricity, the friction (sliding resistance) of the guide wire 1 is reduced, and the slidability is improved. Therefore, the operability of the guide wire 1 is improved.

  Examples of hydrophilic materials include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer). Acrylamide polymer substances (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

  Such a hydrophilic material often exhibits lubricity by wetting (water absorption), and has a friction resistance (sliding resistance) with a catheter (tubular body) or an inner wall of an endoscope used together with the guide wire 1. To reduce. Thereby, the slidability of the guide wire 1 is improved, and the operability of the guide wire 1 in the catheter becomes better.

  As described above, the contrast unit 7 is divided into the first contrast region 71, the second contrast region 72, and the third contrast region 73. The second contrast area 72 is set to have a lower contrast than the first contrast area 71 and the third contrast area 73. Since the configurations (structures) of the first contrast region 71 and the third contrast region 73 are substantially the same, hereinafter, the first contrast region 71 and the second contrast region 71 will be representatively represented by the first contrast region 71 and the second contrast region 71. A difference in contrast between the contrast region 72 and the contrast region 72 will be described.

  As shown in FIG. 1, the coil 6 has a spiral pitch in the second contrast region 72 larger than the spiral pitch in the first contrast region 71. That is, the coil 6 has a loose winding (low arrangement density) in which the adjacent wire rods are separated from each other in the second contrast region 72, and the adjacent wire rods are in close contact with each other in the first contrast region 71. Winding (high arrangement density).

  Further, in the contrast unit 7, the content of the contrast agent (metal powder) in the coating layer 5 (hereinafter, this coating layer 5 is referred to as “coating layer 52”) in the second contrast region 72 is the first contrast region. 71 is less than the content of the contrast agent in the coating layer 5 (hereinafter, this coating layer 5 is referred to as “coating layer 51”).

  As described above, in the contrast unit 7, the first contrast region 71 and the second contrast region 72 are determined depending on the spiral pitch of the coil 6 (the arrangement density) and the contrast agent content. There is a difference in contrast between the two. As a result, a strong contrast region (strong contrast portion) located on both ends of the contrast portion 7 and a weak contrast region (weak contrast portion) located between these strong contrast regions are formed.

By providing such a contrast unit 7, the following effects can be obtained.
The contrast unit 7 has an X-ray contrast property as a whole, but has a strong and weak X-ray contrast property. The first contrast region 71 (strong contrast region) and the second contrast region 72 (weak contrast region). And the third contrast region 73 (strong contrast region) has a clear difference in brightness, that is, excellent contrast. Thereby, the position of the distal end portion (contrast portion 7) of the guide wire 1 can be grasped separately from other positions, and the distal end portion of the guide wire 1 can be grasped by distinguishing it into three places. Therefore, it is advantageous to provide such a contrast unit 7. In particular, the third contrast region 73 can be more reliably confirmed (viewed) using the second contrast region 72 as a clue.

  For example, when the guide wire 1 is inserted into a target site of a living body lumen such as a bile duct under fluoroscopy, where the distal end portion of the guide wire 1 and each part thereof are located in the living body lumen, That is, it is possible to reliably grasp the degree of insertion depth of the guide wire 1 with respect to the target site. In addition, this makes it possible to ensure the insertion depth without excess or deficiency, thereby reliably preventing unintentional disconnection (detachment) of the guide wire 1 from the target site.

  Such an effect is obtained when each contrast region of the contrast unit 7 expresses X-ray contrast only with the coil 6 or when each contrast region of the contrast unit 7 expresses X-ray contrast only with the contrast medium. Is not available.

  Further, when the coil 6 is fixed to the wire body 2, if the coil 6 is fixed with a fixing material such as solder or adhesive, the fixing portion has higher rigidity than the other portions. In addition, since the coating layer 51 and the coating layer 53 are each provided with a larger amount of contrast agent than the coating layer 52, the adhesion to the coil 6 and the wire body 2 is higher than that of the coating layer 52, depending on the constituent material. Is also low.

  However, in the guide wire 1 (contrast part 7), since the coating layer 52 is set so that the content of the contrast agent contained therein is small (including the case where the content is zero), the coil 6 and the wire body 2 is excellent in adhesion to the coil 6 and can be mainly fixed to the coil 6 and the wire body 2 of the entire coating layer 5. Moreover, in the boundary part between the coating layers 51-53, the whole coating layer 5 (coating layers 51-53) and the coil 6 are reliably fixed with respect to the wire main body 2, coupled with the fixing effect due to the compatibility of the resin materials. Is done. Thereby, it is possible to omit fixing the coil 6 with the fixing material, and thus it is possible to reliably suppress the rigidity from being increased at the distal end portion of the guide wire 1, that is, the flexibility of the distal end portion of the guide wire 1. Sex can be reliably maintained.

  The arrangement density of the coils 6 in the first contrast area 71 is not particularly limited, but is preferably 3 to 7 times the arrangement density of the coils 6 in the second contrast area 72, for example. It is more preferably 7 times.

  Further, the content of the contrast agent in the coating layer 52 is not particularly limited. For example, the content of the contrast agent in the coating layer 51 is preferably 10% or less, more preferably 5% or less. . Note that the content of the contrast agent in the coating layer 52 may be zero.

  Under such various conditions, the contrast portion 7 that is superior in contrast can be obtained. Therefore, the operability when the guide wire 1 is inserted into the target site of the living body lumen is enhanced.

  As described above, the configurations of the first contrast region 71 and the third contrast region 73 are substantially the same. For this reason, the first contrast region 71 and the third contrast region 73 have the same degree of contrast. Thereby, since the structure of the 1st contrast area | region 71 and the 3rd contrast area | region 73 is the same, manufacture of the contrast part 7 becomes easy.

  As shown in FIG. 1, the length L1 of the first contrast region 71 is longer than the length L2 of the second contrast region 72. Further, the length L2 of the second contrast region 72 is longer than the length L3 of the third contrast region 73. When the guide wire 1 is inserted to a predetermined position (target site) in the living body lumen, first, the entire first contrast region 71 having the maximum length can be surely inserted. At this time, since the lengths of the respective contrast regions have such a magnitude relationship, the guide wire 1 can be inserted to such an extent that the guide wire 1 does not unintentionally come out of the insertion site. Then, the guide wire 1 is further advanced by using the second contrast region 72 and the third contrast region 73 as marks, and is necessary for the guide wire 1 to reach a predetermined position (target site) of the living body lumen. A length of minutes can be inserted.

  The color of the coating layer 52 is preferably different from any color of the coating layer 51 and the coating layer 5 in the third contrast region 73 (hereinafter, this coating layer 5 is referred to as “coating layer 53”). In particular, it is more preferable that the color of the coating layer 52 is a chromatic color (for example, blue), and each color of the coating layer 51 and the coating layer 53 is an achromatic color (for example, black). With such a color (color arrangement), for example, when the guide wire 1 is inserted to a predetermined position (target site) in the living body lumen through the endoscope, the degree of insertion depth is determined while observing with the endoscope. I can grasp it. Thereby, while being able to confirm the position of the front-end | tip part of the guide wire 1 reliably under X-ray fluoroscopy, it can also confirm reliably also with an endoscope.

  A method for applying a color to each of the coating layers 51 to 53 is not particularly limited, and examples thereof include a method of adding a pigment to the resin material constituting each layer.

  Moreover, it does not specifically limit as a formation method of the coating layers 51-53 from which content of contrast agent differs, For example, the following method is mentioned.

  First, a portion of the wire body 2 to which the coil 6 is attached is masked at portions other than the portions where the coating layers 51 and 53 are formed. In this state, a material constituting the coating layers 51 and 53, that is, a resin material to which a contrast agent is added is applied to the portions where the coating layers 51 and 53 are formed.

Next, the masking of the portion forming the coating layer 52 is removed, and the coating layers 51 and 53 are masked. In this state, the material forming the coating layer 52 is applied to the portion where the coating layer 52 is to be formed.
Through these steps, the covering layers 51 to 53 can be formed.

  Moreover, although the wire main body 2 is contacting the inner surface of the coil 6 in this embodiment, it is not limited to this, For example, you may become non-contact with the inner surface of the coil 6. FIG. In this case, it is preferable that the distal end side portion (outer diameter gradually decreasing portion 15) of the wire body 2 is inserted through a substantially central portion inside the coil 6.

  Further, in the present embodiment, the coil 6 is composed of one continuous wire from the first contrast region 71 to the third contrast region 73. However, the present invention is not limited to this. For example, the coil 6 includes three contrast regions. Three corresponding coils may be connected. In this case, the coil 6 may be composed of different materials on the distal end side and the proximal end side.

Second Embodiment
FIG. 2 is a longitudinal sectional view showing a guide wire (second embodiment) as a reference example .

Hereinafter, a guide wire (second embodiment) as a reference example will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and description of similar matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the resin coating layer is different.

  In the coating layer 5A of the guide wire 1A shown in FIG. 2, the contrast agent content contained in each of the coating layers 51 to 53 is substantially not large, that is, the contrast agent content is the same. However, the contrast medium in the coating layer 52 has a contrast capability lower than that of the contrast medium in the coating layer 51 (the same applies to the coating layer 53). Due to the synergistic effect of the contrast ability of the contrast agent and the helical pitch of the coil 6, a contrast difference occurs between the first contrast region 71 and the second contrast region 72. As a result, as in the first embodiment, the contrast unit 7 has excellent contrast, and thus the degree of insertion depth when the guide wire 1A is inserted into the target site of the biological lumen under fluoroscopy. Can be surely grasped.

  In order to cause the contrast medium to have high or low contrast ability, for example, the contrast agent (particles) in the coating layer 51 and the contrast agent (particles) in the coating layer 52 are made of different materials. The combination of the constituent materials is not particularly limited. For example, the contrast agent in the coating layer 51 can be made of tungsten, and the contrast agent in the coating layer 52 can be made of bismuth oxide. In addition, the contrast agent in the coating layer 51 can be composed of tungsten, and the contrast agent in the coating layer 52 can be composed of barium sulfate.

<Third Embodiment>
FIG. 3 is a longitudinal sectional view showing a third embodiment of the guide wire of the present invention.

  Hereinafter, the third embodiment of the guide wire of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the shape of the tip of the wire body is different.

  In the guide wire 1 </ b> B shown in FIG. 3, a constant outer diameter portion 17 is formed on the wire body 2 further from the outer diameter gradually decreasing portion 15 to the distal end side. Thereby, the rigidity of the portion on the distal end side of the wire body 2 can be gradually decreased as a whole toward the distal end direction, and as a result, the guide wire 1B obtains good flexibility at the distal end portion, The followability to the blood vessel and safety can be improved, and bending and the like can be prevented.

  The contrast unit 7 is formed so as to straddle between the outer diameter constant portion 17 and the outer diameter gradually decreasing portion 15. In this contrast unit 7, the first contrast region 71 is located in the constant outer diameter portion 17, and the second contrast region 72 and the third contrast region 73 are located in the outer diameter gradually decreasing portion 15.

  In the configuration shown in FIG. 3, the formation position of the constant outer diameter portion 17 is formed at the most distal portion of the wire body 2, but is not limited to this. It may be formed in the middle of the gradual decrease portion 15.

  Further, the surface layer 4 covers the entire guide wire 1B, that is, from the distal end to the proximal end. Thereby, the friction (sliding resistance) of the guide wire 1 can be reduced and the slidability can be further improved, and the operability of the guide wire 1 is further improved.

<Fourth embodiment>
FIG. 4 is a longitudinal sectional view showing a fourth embodiment of the guide wire of the present invention.

Hereinafter, the guide wire according to the fourth embodiment of the present invention will be described with reference to the drawings. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the contrast member is different.

  In the guide wire 1 </ b> C shown in FIG. 4, a plurality of ring members (contrast rings) 8 having a ring shape are installed as contrast members having X-ray contrast properties. These ring members 8 are arranged along the longitudinal direction of the wire body 2, and the wire body 2 (outer diameter gradually decreasing portion 15) is inserted through the inside thereof. Further, the inner peripheral surface of each ring member 8 is in close contact with the outer peripheral surface of the wire body 2.

  The average pitch in the second contrast region 72 between the adjacent ring members 8 is larger than the average pitch in the first contrast region 71 and the third contrast portion 73. Further, in the first contrast region 71, a ring member contact portion 81 where the adjacent ring members 8 are in close contact with each other and a ring member separation portion 82 where the adjacent ring members 8 are separated from each other are formed. The ring member contact portion 81 is located on the tip side of the ring member separation portion 82.

  In the guide wire 1 </ b> C, a contrast difference occurs between the first contrast region 71 and the second contrast region 72 due to the size of the pitch and the content of the contrast agent. As a result, as in the first embodiment, the contrast unit 7 has excellent contrast. Therefore, the degree of insertion depth when the guide wire 1C is inserted into the target site of the living body lumen under X-ray fluoroscopy. Can be surely grasped.

  Further, in the guide wire 1C, since the plurality of ring members 8 are used as the contrast member, the pitch can be easily made large or small.

  In addition, although it does not specifically limit as a constituent material of each ring member 8, For example, the constituent material quoted by description about the coil 6 of the said 1st Embodiment can be used.

  In the present embodiment, each ring member 8 has a quadrangular (particularly rectangular) cross section, but the present invention is not limited to this, and the cross section is, for example, elliptical or circular. Also good.

  As mentioned above, although the guide wire of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a guide wire is a thing of arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  In addition, the guide wire of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In addition, the use of the guide wire of the present invention is not limited to the use in the above-described transendoscopic procedure, for example, an operation for treating CTO (Chronic Total Occlusion), angiography, PTCA, and the like. It can also be used.

  The contrast unit has three contrast regions, but may further have one or two or more contrast regions on the proximal end side with respect to the third contrast region. In this case, it is preferable that adjacent contrast regions have different contrast strengths.

  The length of the second contrast region is longer than the length of the third contrast region, but is not limited to this, and may be the same as the length of the third contrast region.

  In addition, the first contrast region and the third contrast region have the same degree of contrast, but are not limited to this and may be different from each other. In this case, the first contrast region may be lower in contrast than the third contrast region, or the first contrast region may be higher in contrast than the third contrast region.

  Further, the contrast agent contained in the coating layer is not limited to a metal powder as long as it is a powder having X-ray contrast properties, and may be, for example, a metal oxide powder. The metal oxide is not particularly limited, and examples thereof include X-ray opaque materials such as barium sulfate, barium carbonate, and bismuth oxide. Among these, barium sulfate and bismuth oxide are preferable. Moreover, a contrast agent may be used individually by 1 type, and may use 2 or more types together (especially mixing). In this case, for example, the contrast agent in the coating layer in the first contrast region and the third contrast region is tungsten (metal material) powder, and the contrast agent in the coating layer in the second contrast region is barium sulfate (metal). Oxide) powder.

It is a longitudinal cross-sectional view which shows 1st Embodiment of the guide wire of this invention. It is a longitudinal cross-sectional view which shows the guide wire (2nd Embodiment) as a reference example . It is a longitudinal cross-sectional view which shows 3rd Embodiment of the guide wire of this invention. It is a longitudinal cross-sectional view which shows 4th Embodiment of the guide wire of this invention.

Explanation of symbols

1, 1A, 1B, 1C Guide wire 2 Wire body 4 Surface layer 5, 5A, 51, 52, 53 Coating layer (resin coating layer)
6 Coil 7 Contrast part 71 1st contrast area 72 2nd contrast area 73 3rd contrast area 8 Ring member (contrast ring)
15 Outer diameter gradually decreasing part (tapered part)
17 Outer diameter constant part L1, L2, L3 Length

Claims (8)

A guide wire having a long wire body and having a contrast portion having an X-ray contrast property formed at the tip,
The contrast portion is provided on the outer peripheral side of the wire body along the longitudinal direction thereof, and is formed of a metal member having an X-ray contrast property, covers the contrast member, and has an X-ray contrast property. And a resin coating layer to which at least a part of the contrast agent is added, and in the first contrast region, the second contrast region, and the third contrast region in order from the distal end side along the longitudinal direction of the wire body. Divided,
The second contrast region has a lower contrast than any of the first contrast region and the third contrast region,
The difference in contrast between the first contrast area and the second contrast area is that the density of the contrast member in the second contrast area is the density of the contrast member in the first contrast area. And the content of the contrast agent in the resin coating layer in the second contrast region is lower than the content of the contrast agent in the resin coating layer in the first contrast region. Has been made,
The difference in contrast between the second contrast area and the third contrast area is that the density of the contrast member in the second contrast area is the density of the contrast member in the third contrast area. And the content of the contrast agent in the resin coating layer in the second contrast region is lower than the content of the contrast agent in the resin coating layer in the third contrast region. Has been made ,
Each resin coating layer is configured at the boundary between the resin coating layer in the first contrast region, the resin coating layer in the second contrast region, and the resin coating layer in the third contrast region. The guide wire is characterized in that the fixing force of the entire resin coating layer in the contrast portion with respect to the contrast member and the wire body is increased in combination with a fixing effect due to the compatibility of the resin materials to be performed.   The resin coating layer in the second contrast region is excellent in adhesiveness to the wire body and the contrast member because the contrast agent content is small, and the wire body of the entire resin coating layer in the contrast portion and The guide wire according to claim 1, which is mainly fixed to the contrast member. The guide wire according to claim 1 or 2 , wherein the constituent material of the contrast member and the contrast agent in the resin coating layer in the first contrast region are made of the same material. And the contrast agent in the resin coating layer in the first imaging area, wherein the second of said contrast agent in the resin coating layer in the imaging area, claims 1 and is composed of different materials from each other 3 A guide wire according to any one of the above. The guide wire according to claim 1 , wherein the contrast agent is a particle made of a metal material or a metal oxide. The contrast member is a coil wound in a spiral shape, and the helical pitch in the second contrast region is larger than the spiral pitch in the first contrast region and the third contrast region. The guide wire according to any one of claims 1 to 5 . The guide wire according to claim 6 , wherein the coil is configured by a single linear body that is continuous from the first contrast region to the third contrast region. The contrast member has a ring shape, and a plurality of the contrast members are arranged along the longitudinal direction of the wire body, and the pitch of the adjacent contrast members in the second contrast region is the first contrast region. The guide wire according to any one of claims 1 to 5 , wherein the guide wire is larger than a pitch in the contrast region and the third contrast region.

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